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Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants Phase I 6

Pas encore en recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07494175 est conçu pour étudier le traitement de Healthy Adult Male. Il s'agit d'une étude interventionnel en Phase I. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 mars 2026, avec un objectif de 6 participants. Dirigée par HENGRUI PHARMA, l'étude devrait être terminée d'ici le 1 avril 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 27 mars 2026.
Résumé succinct
To evaluate the absorption, metabolism and excretion after a single intravenous bolus of \[14C\]HRS-9190 in healthy Participants
Titre officiel

Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants

Pathologies
Healthy Adult Male
Autres identifiants de l'étude
  • HRS-9190-103
Numéro NCT
NCT07494175
Date de début (réel)
2026-03
Dernière mise à jour publiée
2026-03-27
Date de fin (estimée)
2026-04
Inscription (estimée)
6
Type d'étude
Interventionnel
PHASE
Phase I
Statut
Pas encore en recrutement
Objectif principal
Traitement
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalTreatment group A: [14C] HRS-9190
[14C] HRS-9190
\[14C\] HRS-9190 for injection
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Total radioactive recovery rate and cumulative total radioactive recovery rate of excreta
From 0 to 120 hours after dosing
Percentage of unchanged HRS-9190 and its metabolites in the total radioactive exposure in plasma
From 0 to 120 hours after dosing
Percentage of unchanged HRS-9190 and its metabolites in urine and feces relative to the administered dose
From 0 to 120 hours after dosing
List of metabolites identified in plasma, urine, and feces
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter Tmax
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter Cmax
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter t1/2
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter MRT
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter AUC
From 0 to 120 hours after dosing
The whole blood-plasma radioactive distribution ratio
From 0 to 120 hours after dosing
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Adverse events
up to 13 days postdose
Plasma concentration of HRS-9190 (metabolites, if necessary)
From 0 to 120 hours after dosing
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Homme
Accepte les volontaires en bonne santé
Oui
  1. The participants have been fully informed of the nature, significance, potential benefits, possible inconveniences, and potential risks and discomforts of the trial prior to its commencement.
  2. Male participants aged between 18 and 45 years old (inclusive);
  3. ASA =I;
  4. Male participants with a body weight of ≥ 50 kg and a body mass index (BMI = weight (kg)/height² (m²)) ranging from 19 to 28 kg/m² (inclusive) during the screening period;
  5. Male participants must agree to use highly effective contraception and refrain from donating semen from the time of signing the informed consent form until 4 months after the last administration of the investigational product.

  1. Participants with a history of or current acute or chronic clinical diseases
  2. Participants with a history of neuromuscular diseases;
  3. Participants with a history of anesthetic complications;
  4. Participants with a history of airway diseases;
  5. Participants who have undergone major surgery within 6 months prior to screening;
  6. During the screening or baseline period: participants with clinically significant abnormal physical examination findings as judged by the investigator;
  7. Participants who test positive for one or more of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), syphilis antibody, or human immunodeficiency virus antibody (anti-HIV);
  8. Participants with a known history of allergy to the study drug; a history of anaphylactic shock; or atopic diathesis;
  9. Participants with contraindications to anesthetic agents;
  10. Participants who use hepatic enzyme inhibitors/inducers (within 1 month prior to dosing), vaccines (within 1 month pre-screening or planned during trial), or any drugs/health products (within 7 half-lives or 14 days pre-dosing);
  11. Participants who have participated in other clinical trials and received investigational products within 3 months prior to screening, or plan to participate in other clinical trials during the trial period;
  12. Participants with history of significant blood loss/transfusion (≥400 mL within 3 months), active tobacco (>5 cigarettes/day), excessive alcohol/coffee consumption, use of interfering substances (e.g., grapefruit, caffeine) within 48h prior to dosing, or evidence of drug abuse;
  13. Participants with difficult venous access;
  14. Occupational radiation workers; individuals with ≥2 CTs or ≥3 X-rays in the past year; participants in radiolabeled trials (within 1 year);
  15. Participants who may be unable to complete the study for other reasons or are deemed unsuitable for enrollment by the investigator.
Jiangsu HengRui Medicine Co., Ltd. logoHENGRUI PHARMA143 essais cliniques actifs à explorer
Contact central de l'étude
Contact: Yuanyuan Huang, +0518-81220121, [email protected]
1 Centres de l'étude dans 1 pays

Shandong

First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital), Jinan, Shandong, 250014, China
Wei Zhao, Investigateur principal
Jianbo Wu, Investigateur principal